Iatrogenic Drug RiskALGOGERNCT04006444
Characterization of the Iatrogenic Drug Risk in Elderly Patients With Chronic Pain Who Consult the Pain Assessment and Treatment Centre at the Nimes University Hospital
An observational study of Iatrogenic Drug Risk and Chronic Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Chronic pain may be an additional risk factor for drug iatrogeny due to its management and also drug non-compliance in the geriatric population. it seems interesting to carry out an inventory of the iatrogenic risk before and after the consultation at the pain centre to enable us to identify the patients most at risk. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Iatrogenic Drug Risk, Chronic Pain
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 16 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: patients aged at least 65 years consulting at the pain centre of the Nîmes University Hospital for chronic pain
Who may be able to join
- The patient must be affiliated or beneficiary of a health insurance
- Patient ≥ 65 years old
- Having an outpatient consultation at the pain centre of the Nîmes University hospital of for chronic pain
- Available for pharmaceutical consultation about 30 minutes
Who cannot join
- It is impossible to give information
- The patient objects to participating in this study
Trial locations and contacts
1 site in 1 country.
About this study
Chronic pain may be an additional risk factor for drug iatrogeny due to its management and also drug non-compliance in the geriatric population.
it seems interesting to carry out an inventory of the iatrogenic risk before and after the consultation at the pain centre to enable us to identify the patients most at risk. This study would make it possible to characterize elderly patients with chronic pain, in order to consider, in a future study, setting up a pharmaceutical consultation.
- Conditions
- Iatrogenic Drug Risk, Chronic Pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the ADE Geriatric risk score
The score is calculated on 10 points based on 3 criteria : number of drugs prescribed, prescription of neuroleptics and the initiation of an anticoagulant prescription less than 3 months old. It classifies patients into 3 risk categories: a low risk level for a score of 0 to 1 point, a medium risk level for a score of 2 to 5 points and a high risk level for a score of 6 to 10 points.
Measured: 2018
Secondary outcomes (1)
rate of patients with a low, medium or high risk level calculated by ADE Geriatric risk score according to the type of pain
The score is calculated on 10 points based on 3 criteria : number of drugs prescribed, prescription of neuroleptics and the initiation of an anticoagulant prescription less than 3 months old. It classifies patients into 3 risk categories: a low risk level for a score of 0 to 1 point, a medium risk level for a score of 2 to 5 points and a high risk level for a score of 6 to 10 points.
Measured: 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start1 Mar 2018
- Primary completion16 Jun 2018
- Study completion16 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iatrogenic Drug RiskStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- geraldine leguelinel, Dr, Principal investigator, CHU NIMES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006444
- Sponsor's protocol ID
- Local/2017/GL-01
- Acronym
- ALGOGER
- Status last verified
- Jun 2019
- First submitted
- 1 Jul 2019
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jambon J, Choukroun C, Roux-Marson C, Viel E, Leguelinel-Blache G. What Is the Medication Iatrogenic Risk in Elderly Outpatients for Chronic Pain? Clin Neuropharmacol. 2022 May-Jun 01;45(3):65-71. doi: 10.1097/WNF.0000000000000505.
PubMed 35579486
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Iatrogenic Drug Risk in Elderly Patients With Chronic Pain Who Consult the Pain Assessment and Treatment Centre at the Nimes University Hospital
- ClinicalTrials.gov ID
- NCT04006444
- Acronym / sponsor ID
- ALGOGER / Local/2017/GL-01
- Conditions
- Iatrogenic Drug Risk, Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 16 Jun 2018 (actual)
- Study completion
- 16 Jun 2018 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic pain may be an additional risk factor for drug iatrogeny due to its management and also drug non-compliance in the geriatric population.
it seems interesting to carry out an inventory of the iatrogenic risk before and after the consultation at the pain centre to enable us to identify the patients most at risk. This study would make it possible to characterize elderly patients with chronic pain, in order to consider, in a future study, setting up a pharmaceutical consultation.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- patients aged at least 65 years consulting at the pain centre of the Nîmes University Hospital for chronic pain
Key inclusion criteria (4 listed)
- The patient must be affiliated or beneficiary of a health insurance
- Patient ≥ 65 years old
- Having an outpatient consultation at the pain centre of the Nîmes University hospital of for chronic pain
- Available for pharmaceutical consultation about 30 minutes
Key exclusion criteria (2 listed)
- It is impossible to give information
- The patient objects to participating in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution of the ADE Geriatric risk score
Time frame: 2018
The score is calculated on 10 points based on 3 criteria : number of drugs prescribed, prescription of neuroleptics and the initiation of an anticoagulant prescription less than 3 months old. It classifies patients into 3 risk categories: a low risk level for a score of 0 to 1 point, a medium risk level for a score of 2 to 5 points and a high risk level for a score of 6 to 10 points.
1 secondary outcome
rate of patients with a low, medium or high risk level calculated by ADE Geriatric risk score according to the type of pain
Time frame: 2018
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Derived from this study: PubMed 35579486Jambon J, Choukroun C, Roux-Marson C, Viel E, Leguelinel-Blache G. What Is the Medication Iatrogenic Risk in Elderly Outpatients for Chronic Pain? Clin Neuropharmacol. 2022 May-Jun 01;45(3):65-71. doi: 10.1097/WNF.0000000000000505.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
geraldine leguelinel, Dr principal investigator
CHU NIMES
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenic Drug Risk and Chronic Pain, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the ADE Geriatric risk score (time frame: 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04006444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023; AzTrials last refreshed its copy on 8 Nov 2026.